Come October 17, and biopharmaceutical company Aegerion Pharmaceuticals Inc. (AEGR: Quote) will face an FDA advisory panel that will review its New Drug Application for Lomitapide, a once-a-day, oral therapy to treat homozygous familial hypercholesterolemia, a rare genetic lipid disorder.
For readers who are new to the New Jersey based Aegerion, here's a brief overview of the upcoming catalyst to watch out for...
The company submitted the New Drug Application to the FDA, seeking approval of Lomitapide, as an adjunct to a low fat diet and other lipid-lowering therapies to reduce cholesterol in patients with Homozygous Familial Hypercholesterolemia, in March of this year. The submission has been classified as a standard review with a decision date set for December 29, 2012.
Before the FDA makes its decision, the Lomitapide NDA is scheduled to be reviewed by an FDA panel of experts on October 17, 2012.
Lomitapide is also under review by the European Medicines Agency for the treatment of Homozygous Familial Hypercholesterolemia.
Homozygous Familial Hypercholesterolemia, or HoFH, results in an accumulation of low-density lipoprotein, often referred to as bad cholesterol in the blood. The treatments that are recommended for HoFH include, dietary modifications plus a combination of currently approved lipid-lowering drug therapies such as statins and in many cases plasma-apheresis, a mechanical filtration used to remove lipids from the blood, similar to kidney dialysis.
However, even with lipid-lowering drug treatments, the amount of low-density lipoprotein, found in patients diagnosed with HoFH will be as much as 3-6 times the ideal level.
Lipid disorders, which refer to abnormalities of cholesterol and triglyceride, are associated with an increased risk for potentially life threatening cardiovascular events, such as stroke, heart attack or pancreatitis (inflammation of the pancreas).
Aegerion's Lomitapide is known to work by preventing liver and intestines from secreting lipids into the blood stream, thereby reducing the lipid levels in the blood. Lomitapide holds orphan drug designation for the treatment of Homozygous Familial Hypercholesterolemia in the United States, and for the treatment of familial chylomicronemia in the US and EU.
Yet another drug candidate for the potential treatment of Homozygous Familial Hypercholesterolemia is KYNAMRO (Mipomersen), developed by Sanofi Aventis (SNY) unit Genzyme and Isis Pharmaceuticals Inc. (ISIS: Quote). KYNAMRO NDA is slated to be reviewed by an FDA panel on October 18, and the decision date is set for January 29, 2013.
A quick look at Aegerion's balance sheet...
Since inception in February, 2005, Aegerion Pharma has incurred significant losses from operations, and at June 30, 2012, had an accumulated deficit of $156.0 million. The company has not generated any revenue to date, and does not expect to generate significant revenue unless or until Lomitapide is approved and commercialized.
For the second quarter ended June 30, 2012, the company's net loss attributable to common stockholders widened to $13.9 million or $0.63 per share from $8.6 million or $0.49 per share in the same period of 2011.
The company ended Q2, 2012 with $64.7 million in cash, which is believed to be sufficient to cover its cash flow requirements through the first quarter of 2014.
Aegerion shares have thus far hit a 52-week low of $11.75 and a 52-week high of $17.72. The stock closed Friday's trading at $15.17, up 1%.
Will Lomitapide clear the penultimate regulatory hurdle of winning the FDA panel backing? Stay tuned...
| || |
| To receive FREE breaking news email alerts for Aegerion Pharmaceuticals Inc. and others in your portfolio|
by RTT Staff Writer
For comments and feedback: firstname.lastname@example.org